Label: COOLA CLASSIC FACE SUNSCREEN WHITE TEA BROAD SPECTRUM SPF 50- avobenzone homosalate octisalate octocrylene lotion
- NDC Code(s): 54111-143-50
- Packager: Bentley Laboratories, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 19, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- DO NOT USE
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
Directions
• apply liberally 15 minutes before sun exposure
• reapply:
• after 80 minutes of swimming or sweating
• immediately after towel drying
• at least every 2 hours
• Sun Protection Measures. Spending time in the sun
increases your risk of skin cancer and early skin aging. To
decrease this risk, regularly use a sunscreen with a broad
spectrum SPF of 15 or higher and after sun protection.
measures including:
• limit time in the sun, especially from 10 a.m. – 2 p.m.
• wear long-sleeve shirts, pants, hats, and sunglasses.
• Children under 6 months: Ask a doctor -
INACTIVE INGREDIENT
Inactive Ingredients
Aloe Barbadensis Leaf Juice (ORGANIC),
Brassica Campestris (Rapeseed) Seed Oil,
Butylene Glycol, Camelina Sativa Seed Oil,
Caprylyl Glycol, Carthamus Tinctorius
(Safflower) Oleosomes, Carthamus
Tinctorius (Safflower) Seed Oil (ORGANIC),
Cetearyl Alcohol, Cetyl Palmitate, Decyl
Glucoside, Dimethicone, Flavor*, Glycerin
(ORGANIC), 1,2-Hexanediol, Limnanthes
Alba (Meadowfoam) Seed Oil, Mauritia
Flexuosa (Buriti) Fruit Oil, Methyl
Dihydroabietate, Opuntia Ficus-Indica
Flower Extract, Polyacrylate
Crosspolymer-6, Polysilicone-11, Rubus
Idaeus (Raspberry) Seed Oil, Silica, Sodium
Hydroxide, Sodium Phytate, Sorbitan
Oleate, Sorbitan Palmitate, Squalane,
Tropolone, Water, Xanthan Gum - OTHER SAFETY INFORMATION
- QUESTIONS
-
Package Label
SPF
5070% +
OrganicCOOLA®
Classic
Face Sunscreen
White TeaNon-Greasy
Lightweight Hydration
+Plant Protection®Broad Spectrum SPF 50
Water Resistant (80 Minutes)1.7 FL OZ/ 50 mL
Hawaii Reef Friendly Sunscreen Oxybenzone & Octinoxate Free
*Naturally Derived
2020 COOLA. Distributed by: COOLA LLC, located in Sunny
& Cool San Diego, CA 92010. BIORUS / EU: 7170 Manage,
Belgium / UK: London WC2H 9JQ. All Rights Reserved.
www.coola.comBox
Tube
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INGREDIENTS AND APPEARANCE
COOLA CLASSIC FACE SUNSCREEN WHITE TEA BROAD SPECTRUM SPF 50
avobenzone homosalate octisalate octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54111-143 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 1.75 g in 100 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 5.0 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 2.0 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 5.0 g in 100 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) BRASSICA RAPA SUBSP. OLEIFERA OIL (UNII: N4G8379626) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) CAMELINA SATIVA SEED OIL (UNII: 12824X01L0) CAPRYLYL GLYCOL (UNII: 00YIU5438U) CARTHAMUS TINCTORIUS SEED OLEOSOMES (UNII: 9S60Q72309) SAFFLOWER OIL (UNII: 65UEH262IS) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CETYL PALMITATE (UNII: 5ZA2S6B08X) DECYL GLUCOSIDE (UNII: Z17H97EA6Y) DIMETHICONE (UNII: 92RU3N3Y1O) GLYCERIN (UNII: PDC6A3C0OX) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y) MAURITIA FLEXUOSA FRUIT OIL (UNII: 48H19MS04L) METHYL DIHYDROABIETATE (UNII: 7666FJ0J9F) OPUNTIA FICUS-INDICA WHOLE (UNII: 23Z87HTQ6P) AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) RASPBERRY SEED OIL (UNII: 9S8867952A) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SODIUM HYDROXIDE (UNII: 55X04QC32I) PHYTATE SODIUM (UNII: 88496G1ERL) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) SORBITAN MONOPALMITATE (UNII: 77K6Z421KU) SQUALANE (UNII: GW89575KF9) TROPOLONE (UNII: 7L6DL16P1T) WATER (UNII: 059QF0KO0R) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54111-143-50 1 in 1 CARTON 11/07/2019 1 50 mL in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 11/07/2019 Labeler - Bentley Laboratories, LLC (068351753)